Study |
Drug of choice vs placebo |
Duration of study |
Subjects |
Results (Drug of choice vs placebo) |
Pols HA et al. [29] (FOSIT) |
10mg oral alendronate per day. |
1 year |
Postmenopausal women with BMD <2. |
BMD were significantly (P < 0.001) greater in the treatment group by 4.9% at the lumbar spine, 2.4% at the femoral neck, 3.6% at the trochanter and 3.0% for the total hip. |
Cummings SR et al. [30] (FIT) |
5 mg oral alendronate per day for two years followed by 10 mg per day for the remaining period of the trial. |
4.2 years |
Women aged 54 to 81 years with a femoral neck BMD of 0.68 g/cm2. |
BMD was significantly (P < 0.001) greater in the treatment group by 3.8% at the femoral neck, 3.4% at the total hip, 8.3% at the lumbar spine. |
Chesnut CH et al. [35] |
Oral ibandronate administered either daily (2.5 mg per day) or intermittently (20 mg every other day for 12 doses every three months). |
3 years |
Postmenopausal women with a BMD T score < –2.0 with 1 to 4 prevalent vertebral fractures. |
BMD was significantly greater in lumbar spine by 6.5% for daily ibandronate treatment group and 5.7% in an intermittent ibandronate treatment group. A significant increase in hip BMD was also observed. |
Mortensen L et al. [38] |
Oral risedronate 5 mg per day daily or oral risedronate 5 mg cyclically for two years followed by one year off treatment. |
3 years |
Early postmenopausal women with normal BMD. |
At the end of the second year of the study, the mean increase in BMD of the lumbar spine was 1.4% from baseline in the daily risedronate treatment group and a decrease in lumbar spine BMD of 1.6% in cyclic risedronate treatment group. At the end of the second year of the study, trochanteric BMD at the hip increased by 5.4% in the risedronate 5 mg daily group and by 3.3% in the risedronate 5 mg cyclic group. During one-year treatment-free period bone turnover was increased and lumbar spine BMD was decreased in all three groups. |